FDA: Manufacturing Disruptions must be reported six Months in Advance

Recommendation

27/28 October 2021

GMP for Medical Devices - EU versus USA - Live Online

Drug shortage has become a serious problem. Besides problems in the distribution chain, reasons could be manufacturing and quality problems, delays, and discontinuations. The U.S. Food and Drug Administration (FDA) takes more and more efforts to address and prevent drug shortages. In the case of shortage, FDA works closely with manufacturers to communicate the issue and to help restore availability. FDA also works with other firms who manufacturer the same drug, asking them to increase production, if possible, in order to prevent or reduce the impact of a shortage.

To do so, the FDA needs information about a potential drug shortage as soon as possible and the majority of drug shortage information is provided to FDA by manufacturers. To ensure information is current, the FDA has now published a final rule (FDA-2011-N-0898 Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products) that requires all drug and biologic manufacturers to notify the agency electronically of a permanent discontinuance or an interruption in manufacturing six months in advance, or as soon as is practical, before the disruption causes a shortage.